(273 days)
Intelligent Dialysis Assistant (IDA) is intended for automatic single exchange of dialysate solution exchanges in the treatment of adult renal failure patients undergoing peritoneal dialysis.
All therapies using the Intelligent Dialysis Assistant (IDA) must be prescribed and performed under the responsibility of a physician who is familiar and well informed about peritoneal dialysis. The patient prescription may include single or multiple exchanges, depending on the patient's need.
The IDA Cartridge is a single-use, sterile cartridge exclusively for use with the IDA. It is intended to interface the IDA with the Twin Bag Set (patient dialysis prescription) and the patient's peritoneal catheter.
The Medical Supervision Portal is intended for use by healthcare professionals to remotely communicate new or modified treatment parameters with compatible dialysis instruments and transfer completed treatment database to aid in the review, analysis, and evaluation of patients' historical treatment results. This Medical Supervision Portal is not intended to be a substitute for good clinical management practices, nor does its operation creatment pathways.
The IDA Smartphone App is a software medical application intended for patients to review their treatment and review and approve their dialysis prescription provided by the healthcare professional through the Medical Supervision Portal. The user is not intended to take clinical action based on the application of a qualified healthcare professional.
Not Found
The provided FDA 510(k) clearance letter for the "Digital Dialysis Clinic - Intelligent Dialysis Assistant (IDA) & IDA Cartridge with Medical Supervision Portal and IDA Smartphone App" primarily focuses on the substantial equivalence determination for regulatory clearance. It does not contain specific details about the acceptance criteria or a detailed study proving the device meets those criteria, as typically found in clinical study reports or more comprehensive device descriptions.
The letter confirms the device's classification, intended use, and substantial equivalence to predicate devices, but lacks the in-depth technical and clinical performance data required to answer your specific questions about acceptance criteria, detailed study methodology, ground truth establishment, or human-AI interaction effects.
Therefore, I cannot provide the requested information from the given text. To answer your questions, you would typically need to consult a detailed clinical study report, a regulatory submission, or technical documentation for the device, which are not included in this FDA clearance letter.
§ 876.5630 Peritoneal dialysis system and accessories.
(a)
Identification. (1) A peritoneal dialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions, and that consists of a peritoneal access device, an administration set for peritoneal dialysis, a source of dialysate, and, in some cases, a water purification mechanism. After the dialysate is instilled into the patient's peritoneal cavity, it is allowed to dwell there so that undesirable substances from the patient's blood pass through the lining membrane of the peritoneal cavity into this dialysate. These substances are then removed when the dialysate is drained from the patient. The peritoneal dialysis system may regulate and monitor the dialysate temperature, volume, and delivery rate together with the time course of each cycle of filling, dwell time, and draining of the peritoneal cavity or manual controls may be used. This generic device includes the semiautomatic and the automatic peritoneal delivery system.(2) The peritoneal access device is a flexible tube that is implanted through the abdominal wall into the peritoneal cavity and that may have attached cuffs to provide anchoring and a skin seal. The device is either a single use peritioneal catheter, intended to remain in the peritoneal cavity for less than 30 days, or a long term peritoneal catheter. Accessories include stylets and trocars to aid in the insertion of the catheter and an obturator to maintain the patency of the surgical fistula in the abdominal wall between treatments.
(3) The disposable administration set for peritoneal dialysis consists of tubing, an optional reservoir bag, and appropriate connectors. It may include a peritoneal dialysate filter to trap and remove contaminating particles.
(4) The source of dialysate may be sterile prepackaged dialysate (for semiautomatic peritoneal dialysate delivery systems or “cycler systems”) or dialysate prepared from dialysate concentrate and sterile purified water (for automatic peritoneal dialysate delivery systems or “reverse osmosis” systems). Prepackaged dialysate intended for use with either of the peritoneal dialysate delivery systems is regulated by FDA as a drug.
(b)
Classification. Class II (special controls). The following accessories are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9: A catheter finger grip that is non-patient contacting and intended for single use with a peritoneal catheter; a continuous ambulatory peritoneal dialysis (CAPD) belt; and a catheter stand that does not include weigh scales.